Pharmacogenomic Drug InteractionTOPMEDsNCT06448091
Trial of Precision Medicine in Emergency Departments
A study testing Panel-based pharmacogenetic genotyping in people with Pharmacogenomic Drug Interaction, run by University of Florida at 3 sites in United States.
Trial summary
The objectives of this study are to (1) test the feasibility of the clinical implementation of preemptive pharmacogenetic (PGx) testing in the emergency department (ED) and (2) determine if PGx testing (with appropriate decision support) decreases ED return visits and hospitalizations. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenomic Drug Interaction
- What is being tested?
- Panel-based pharmacogenetic genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Mar 2025to 1 Feb 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 40 years or older presenting to a participating ED
- Receipt of a new order/prescription for a selected PGx medication (Appendix 1), with a duration greater than 7 days, during the current ED visit or within 30 days prior.
- Documentation of at least 2 prior ED or urgent care visits within the past 12 months
Who cannot join
- Prior clinical pharmacogenetic test results within the EHR for genes relevant for this study (Appendix 1).
- History of hepatic or renal transplant
- History of severe liver disease (stage Child-Pugh C) or renal disease eGFR <15 ml/min.
- Any medical condition that would prohibit the ability to complete the study
- Prisoners, wards of the state, or patients being held under the Baker Act or Marchman Act
- Life expectancy less than 6 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
UF Health Emergency Department
Gainesville, Florida, 32610
Erica Elwood, MHA, 352-273-6007, erica.elwood@cop.ufl.edu
- Recruiting
UF Health Jacksonville Downtown Emergency Department
Jacksonville, Florida, 32209
Morgan Henson, MPH, 904-244-4234, morgan.henson@jax.ufl.edu
Sophia Sheikh, MD
- Recruiting
UF Health Jacksonville North Emergency Department
Jacksonville, Florida, 32218
Morgan Henson, MPH, 904-244-4234, morgan.henson@jax.ufl.edu
Sophia Sheikh, MD
About this study
The objectives of this study are to (1) test the feasibility of the clinical implementation of preemptive pharmacogenetic (PGx) testing in the emergency department (ED) and (2) determine if PGx testing (with appropriate decision support) decreases ED return visits and hospitalizations. We will conduct a randomized, controlled, pragmatic clinical trial assessing both the real-world effectiveness as well as implementation outcomes using a targeted PGx testing panel in several UF Health EDs.
- Conditions
- Pharmacogenomic Drug Interaction
- Being tested
- Panel-based pharmacogenetic genotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panel-based pharmacogenetic genotypingDiagnostic test
After consent and randomization into the immediate PGx testing, participants' results will (10-14 days after randomization) go into their EHR and be returned via a laminated results card
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Immediate panel-based pharmacogenetic genotyping | Experimental | Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and have their results both entered into their electronic health record as well as provided to them within 2-4 weeks from randomization. Receives: Diagnostic Test: Panel-based pharmacogenetic genotyping |
| Delayed panel-based pharmacogenetic genotyping | No intervention | Subjects assigned to delayed panel-based pharmacogenetic genotyping will not be tested until after their participation in the study has ended (6 months after enrollment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED recidivism
The primary effectiveness outcome for the trial will be ED recidivism between participants assigned to PGx testing (intervention) compared to those assigned to delayed genotyping (usual care) within 6 months. Specifically, the rate of return visits related to their prior medical problem, identified through a matching primary diagnosis code or clinical impression abstracted from the EHR.
Measured: Baseline to 6 months
Rate of Clinician review of PGx results
The primary implementation outcome will be the rate at which clinicians review the PGx results. This will include both viewing of CDS alerts within the UF Health EHR or viewing individualized PGx recommendations routed from patient PGx results cards.
Measured: Return of Results to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start18 Mar 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacogenomic Drug InteractionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Julio D Duarte, Pharm.D., Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448091
- Sponsor's protocol ID
- IRB202301675
- Other IDs
- R01HG013416
- Acronym
- TOPMEDs
- Status last verified
- Jun 2026
- First submitted
- 31 May 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No